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Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02716909
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Gabriele Saccone, Federico II University

Tracking Information
First Submitted Date  ICMJE March 6, 2016
First Posted Date  ICMJE March 23, 2016
Last Update Posted Date June 18, 2018
Study Start Date  ICMJE March 2016
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2016)
Spontaneous preterm birth (SPTB) <34 weeks [ Time Frame: Less than 34 weeks gestation ]
Spontaneous preterm delivery less than 34 weeks of gestation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2016)
  • SPTB <37w [ Time Frame: Less than 37 weeks gestation ]
  • SPTB <32w [ Time Frame: Less than 32 weeks gestation ]
  • SPTB <28w [ Time Frame: Less than 32 weeks gestation ]
  • Gestational age at delivery [ Time Frame: Time of delivery ]
  • Latency [ Time Frame: time of delivery ]
    interval from randomization to delivery in days
  • preterm premature rupture of membranes [ Time Frame: Less than 34 weeks gestation ]
  • Type of delivery [ Time Frame: time of delivery ]
    Cesarean delivery, operative vaginal delivery and spontaneous vaginal delivery
  • Maternal side effects [ Time Frame: Time of delivery ]
    Vaginal discharge, bacterial vaginosis
  • Birth weight [ Time Frame: Time of delivery ]
  • Neonatal death [ Time Frame: Between birth and 28 days of age ]
  • perinatal death [ Time Frame: fetal death after 20 weeks ]
    either fetal mortality or neonatal death
  • Composite adverse perinatal outcome [ Time Frame: Between birth and 28 days of age ]
    Includes necrotizing enterocolitis, Intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia (BPD), retinopathy, blood-culture proven sepsis, and neonatal death
  • Chorioamnionitis [ Time Frame: Time of delivery ]
  • Adminssion to neonatal intensive care unit [ Time Frame: Between birth and 28 days of age ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth
Official Title  ICMJE Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth
Brief Summary

Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. In singleton gestations a short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB.

The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with a short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on the use of cervical pessary in pregnancy or guidelines for management have been assessed.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Preterm Birth
Intervention  ICMJE Device: Cervical pessary
The cervical pessary is a silicone device that has been used to prevent SPTB Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)
Study Arms  ICMJE
  • Experimental: Cervical Pessary
    The cervical pessary is a silicone device that has been used to prevent SPTB Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)
    Intervention: Device: Cervical pessary
  • No Intervention: No intervention
    No pessary No pessary will be used. Subjects will receive standard obstetrical management
Publications * Saccone G, Maruotti GM, Giudicepietro A, Martinelli P; Italian Preterm Birth Prevention (IPP) Working Group. Effect of Cervical Pessary on Spontaneous Preterm Birth in Women With Singleton Pregnancies and Short Cervical Length: A Randomized Clinical Trial. JAMA. 2017 Dec 19;318(23):2317-2324. doi: 10.1001/jama.2017.18956. Erratum in: JAMA. 2018 May 1;319(17 ):1824.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 17, 2016)
300
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18-50 years of age
  • Singleton pregnancy (limits the participants to female gender)
  • Short cervical length (less than or equal to 25 mm) on second trimester transvaginal ultrasound at 18-23 6/7 weeks gestation

Exclusion Criteria:

  • Multiple gestation
  • Prior spontaneous preterm birth 16-36 6/7 weeks
  • Ruptured membranes
  • Lethal fetal structural anomaly
  • Fetal chromosomal abnormality
  • Cerclage in place (or planned placement)
  • Vaginal bleeding
  • Suspicion of chorioamnionitis
  • Ballooning of membranes outside the cervix into the vagina or CL = 0 mm on transvaginal ultrasound
  • Painful regular uterine contractions
  • Placenta previa
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02716909
Other Study ID Numbers  ICMJE 213/2015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gabriele Saccone, Federico II University
Study Sponsor  ICMJE Federico II University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Federico II University
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP